Contraception Behavior, Counseling, Pregnancy in Adolescence
Conditions
Keywords
Contraception counseling, Adolescent pregnancy, Contraception initiation
Brief summary
This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).
Detailed description
This study is a prospective cohort study involving females who present to one of two emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended pregnancy. Our primary objective is to assess intention to initiate contraception (high=very/somewhat likely vs low=unsure/not likely/definitely not on Likert scale survey) among females aged 15 to 18 years who receive emergency department-based contraceptive counseling. Our secondary objectives are as follows: 1. Among the same population, assess completion of a referral for any contraceptive care, defined as attendance at a referral site within 4 weeks after the index ED visit. 2. Assess the proportion who ultimately initiate contraception through electronic medical record documentation (i.e., visit note, procedure note, medication review) and participant report (follow-up calls). 3. Use qualitative interview methodology to explore attitudes, barriers, and facilitators that affect decisions to A) express intention to initiate contraception, B) complete a referral for contraceptive care, and C) ultimately initiate contraception among this unique group of high-risk adolescents.
Interventions
BEHAVIORALContraception Counseling
Each participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department
Sponsors
Children's Mercy Hospital Kansas City
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Contraception counseling will occur for all adolescent participants and APPs will be enrolled to conduct counseling. The number of participants enrolled includes the final number of participants including adolescent and APPs.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females aged 15-18 years who are at high-risk of pregnancy, defined as sexual activity within the last 6 months or likely future sexual activity. 2. Females who do not desire to become pregnant within the next year. 3. Eligible individuals must be proficient in speaking and reading in English. 4. Consent of the adolescent.
Exclusion criteria
1. Females who are currently using hormonal contraception or an intrauterine device. 2. Females who are pregnant. 3. Patient has a developmental delay limiting participation. 4. Patient is presenting in the ED after sexual assault. 5. Patient is too ill to be screened. APPs: \[no age limit\]\] Have been working in ED 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Initiate Contraception | up to 8 weeks | Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Care Referral Completion | up to 8 weeks | Participants completed a referral visit for any contraception care |
| Initiation of Contraception | up to 12 weeks | Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Unique Themes Affecting Decision-Making | up to 12 weeks | Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants). Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB. |
Countries
United States
Participant flow
Recruitment details
Adolescents and APPs were enrolled from Emergency Departments of two geographically distinct urban pediatric hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Adolescent Counseling Intervention All adolescent participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department
Please note, no baseline measures were collected for APP participants. | 96 |
| APP Contraception Counseling Training All adolescent participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department
Please note, no baseline measures were collected for APP participants. | 0 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Determined to be ineligible or there was no APP to perform the counseling. | 9 | 0 |
Baseline characteristics
| Characteristic | APP Contraception Counseling Training | Total | Adolescent Counseling Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 96 Participants | 96 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | — | 16.8 years | 16.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 16 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 79 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 0 Participants | 96 Participants | 96 Participants |
| Sex: Female, Male Female | 0 Participants | 96 Participants | 96 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 27 |
| other Total, other adverse events | 0 / 99 | 0 / 27 |
| serious Total, serious adverse events | 0 / 99 | 0 / 27 |
Outcome results
Primary
Intention to Initiate Contraception
Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses
Time frame: up to 8 weeks
Population: Those who reported high intention to initiate contraception
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Counseling Intervention | Intention to Initiate Contraception | 59 Participants |
Secondary
Contraceptive Care Referral Completion
Participants completed a referral visit for any contraception care
Time frame: up to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Counseling Intervention | Contraceptive Care Referral Completion | 35 Participants |
Secondary
Initiation of Contraception
Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys
Time frame: up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Counseling Intervention | Initiation of Contraception | 32 Participants |
Other Pre-specified
Number of Unique Themes Affecting Decision-Making
Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants). Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB.
Time frame: up to 12 weeks
Population: The total number of unique themes for all participants was reported based on qualitative analysis. 28 adolescents participated in interviews out of the total number of adolescents enrolled in the study. This portion of the study was optional.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adolescent Counseling Intervention | Number of Unique Themes Affecting Decision-Making | 6 themes |